Dr. Peter Marks, the head vaccine regulator for the Food and Drug Administration (FDA), announced Tuesday that his team is close to authorizing updated doses meant to target the latest version of the virus. Marks said that he is “extremely confident” that the shots are safe and will be effective since the FDA has “extremely good” data, even though these versions of the vaccines have not been tested in humans, according to The New York Times.
Both Pfizer-BioNTech and Moderna finalized their submissions to the FDA this week questioning for emergency authorization of booster shots directed at BA.5 and another subvariant of Omicron, which together accounts for the most COVID-19 cases in the nation, the Times adds.
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President Biden’s chief medical adviser, Dr. Anthony Fauci, announced Tuesday that “we have got to do better to protect the American public. We are in the middle of a BA.5 outbreak here and nowhere near where we want to be.”
Some scientists think the government is moving too fast to approve new shots since existing vaccines already strongly protect against severe cases. John P. Moore, a virologist at Weill Cornell Medicine, announced that “deaths are concentrated in unvaccinated people and people with serious health conditions” and that protection from new shots could be “weak to nonexistent.”
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Jeremy Kamil, a virologist at Louisiana State University Health Shreveport, supports new boosters yet thinks that enough people already have immunity for it not to matter, stating, “even if we get this out in the next 10 days, how many people are left who haven’t gotten Omicron?”
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However, Dr. Marks thinks that the plan makes sense since the virus has changed and immunity may wane over time, declaring that if regulators wait for more data, the virus may mutate more and “we may have lost a bunch of individuals who could otherwise be sitting around at the dinner table together.”
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The Center for Disease Control (CDC) has scheduled a two-day meeting of its advisory panel of specialists on the matter for September 1 and 2, after which CDC director Rochelle Walensky would make a final decision on introducing the new doses. The plan is to offer the new Pfizer shots to everyone 12 and older, while offering the Moderna version to adults only.
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